Development & Evaluation of Pneumatic Artificial Muscle(PAM) for Patients With Ankle Foot Orthosis(AFO)

May 29, 2024 updated by: Muhammad Naveed Babur, Superior University
Pneumatic Artificial Muscles (PAMs), inspired by the structure and function of natural muscles, offer a lightweight and adaptable solution compared to traditional rigid Ankle Foot Orthosis(AFOs).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The development process involves design optimization to ensure proper, fit, functionality and durability. Researchers utilize advanced materials and manufacturing techniques to create PAMs that mimic the natural movement of the ankle joint while providing sufficient support and flexibility. Evaluation of PAMs involves rigorous testing in both laboratory settings and real world environments. Bio-mechanical analysis assesses the performance of PAMs during various activities such as walking, running and stair negotiation. Critical trails involving patients with AFOs provide valueable feedback on usability, comfort and overall satisfaction. Additionally, long-term studied monitor the durability and reliability of PAMs over extended periods of use. Overall, the development and evaluation of PAMs for patient with AFOs represent a significant advancement in assistive technology. By offering a more natural and adaptive solution for gait assistance, PAMs enhance mobility, independence and quality of life for individuals with mobility impairments.

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Faisalābad, Punjab, Pakistan
        • Al-Ghani rehabilitation centre. Opposite to Misaq-ul-mall

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of droop foot
  • Ability to tolerate pneumatic pressure
  • Sufficient muscle strength activation

Exclusion Criteria:

  • Allergy to materials used in device fabrication
  • Severe muscle weakness preventing activation
  • Uncontrolled hypertension, pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PneuFlex AFO Assist
Diagnostic test: PneuFlex AFO Assist
It features a pneumatic artificial muscle designed to enhance ankle foot orthosis functionally for patients with mobility issues.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Mobility
Time Frame: 12 months
Functional mobility is a person's physiological ability to move independently and safely in a variety of environments in order to accomplish functional activities or tasks and to participate in the activities of daily living, at home, work and in the community
12 months
Range of motion (ROM)
Time Frame: 12 months
Range of motion means the extent or limit to which a part of the body can be moved around a joint or a fixed point; the totality of movement a joint is capable of doing. Range of motion of a joint is gauged during passive ROM (assisted) PROM or active ROM (independent) AROM.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Superior University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 29, 2024

First Posted (Actual)

June 3, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 29, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSRSW/Batch-Fall22/703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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